Kornimate/medical-research-clean huggingface dataset:
normal versus dual wave insulin bolus for high-protein food

Conditions: Type 1 Diabetes

Summary: patients receive a standardized high-protein test meal at breakfast time. insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. the 3h post-meal glucose excursions will be recorded by self-blood glucose measurements (smbg) (every 1 hour) and continuous glucose monitoring system (cgms). the intervention is taking part under in-patient clinical conditions.

the dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient. the aim of this study is to compare post-prandial glycaemic excursions following a high-protein meal after administration of insulin by normal vs dual-wave bolus. during this prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes, treated with insulin pump therapy will be evaluated using the self-blood glucose measurements following standardized high-protein meal and two types of boluses (normal or dual-wave). the required insulin dose will be calculated based on patient's insulin-exchange ratio. a high-protein meal will be given on two subsequent breakfasts and comparisons will be made between normal and dual-wave insulin bolus delivery. prolonged post-prandial glycaemic excursions will be identified using the cgms.

Eligibility criteria:
inclusion criteria: * duration of type 1 diabetes longer than 12 months * insulin pump therapy longer than 3 months * written informed consent by patients and parents * patients must be willing to wear a glucose sensor for two days * insulin requirement more than 0,5 units/kg/day exclusion criteria: * concomitant dietary restrictions (e.g. celiac disease or food allergy) * diabetes related complications (e.g. nephropathy) * any disease judged by the investigator to affect the trial * withdrawal of consent to participate in the study

Keywords: dual-wave bolus square bolus normal bolus standard bolus high-protein meal prandial insulin requirement
covid-19 vaccine responses in patients with inflammatory bowel diseases

Conditions: IBD; Covid19

Summary: the 2019-coronavirus disease (covid-19), caused by sars-cov-2, was identified as the source of pneumonia cases in wuhan city in china. it rapidly spread worldwide and was declared by who as a pandemic. covid-19 vaccines are expected to be the breakthrough in controlling the pandemic. however, studies performed only in healthy adults, and specifically excluded patients who were under immunomodulatory/biologic therapy, thus excluding patients with chronic inflammatory diseases (ibd). in this study we wish to understand vaccine efficacy and immunological response in ibd patients.

overall aims: 1. to assess the immune response to covid-19 vaccination in patients with ibd. 2. comparing the short and long term immune response to vaccination among subgroups receiving different therapies. 3. to evaluate the different variables affecting immunity of these patients. 4. to assess adverse reactions to covid-19 vaccines and ibd related complications. specifically: 1. to assess serologic response to covid-19 vaccine(s) in patients with ibd treated with anti-tnf agents (+/- immunomodulators) compared to 1. healthy controls 2. patients with ibd not treated with anti-tnf (+/- immunomodulators) 2. to characterize serologic response: seroconversion, seroprotection and persistence of covid-19 vaccine(s) in patients with ibd 3. to identify factors associated with serologic response 4. side effects to vaccines 5. ibd exacerbation compared to activity at baseline 6. symptomatic covid-19

Eligibility criteria:
inclusion criteria: * 1. adults \>18 years of age 2. patients with either crohn's disease, ulcerative colitis, ileostomy, pouch 3. not vaccinated to covid-19 \[i.e. before 2 mrna pfizer vaccines provided, or before any vaccine provided as one injection 4. ability to attend follow up visits 5. ability to understand and sign an informed consent form exclusion criteria: * 1. pregnant women
developing criteria for cortical resections

Conditions: Epilepsy; Tumor

Summary: the purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain.

the purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. during surgery small pieces of abnormal (unusual) brain tissue may be removed. we analyze these specimens using more advanced microscopic and electrophysiologic techniques than are usually applied to such tissue specimens. in addition, some tissues can be maintained in laboratory conditions to allow analysis over the longer term. no extra brain tissue is taken to perform these studies. the tissue analysis is performed by the research team and are compared to the routine (normal) electrical recordings that are taken during this type of brain surgery. currently there are no instructions telling a doctor how much brain tissue should be cut out to prevent the spread of tumors or epilepsy. we are hoping that the results of this study help us to better know how much brain tissue needs to be removed to prevent the spread of tumors or epilepsy.

Eligibility criteria:
inclusion criteria: * surgical candidates with epilepsy or brain tumor(s)

Keywords: epilepsy tumor surgery brain
pilot study of dmri as a tool for early evaluation of tumor response in diffuse large b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: this research study is designed to test whether the results of a diffusion mri scan performed after one cycle of chemotherapy for lymphoma can accurately predict the outcome of treatment for individual patients.

different types of functional imaging are under investigation as a tool to predict response to treatment, as imaging soon after starting therapy might be able to better define the likelihood of response. functional imaging refers to scans that measure characteristics other than size and shape (anatomic imaging), as measured by ct scans. we are interested in evaluating the potential value of diffusion magnetic resonance imaging (dmri), which in some settings can be used very early in treatment in predicting patients' response to treatment. diffusion mri (dmri) detects changes in cell structure, and has the potential to detect and measure cell changes that occur in response to treatment. several groups are investigating the use of dmri to monitor treatment responses. this strategy has been most frequently explored in humans in patients with brain tumors, where dmri has been demonstrated to predict response to treatment early after starting treatment. a few studies have looked at response in other cancers. these studies showed early changes in patients who later responded to treatment, with changes seen within one to 2 weeks. although diffusion mri has been shown to be useful in several cancer types, it has not been explored in the evaluation of lymphoma. this pilot study will evaluate the imaging characteristics of diffuse large b-cell lymphoma (dlbcl) by dmri prior to treatment and 7 days after initial chemotherapy in order to explore whether dmri is useful in evaluating the response of lymphoma to chemotherapy.

Eligibility criteria:
inclusion criteria: * patients with a new diagnosis of cd20 positive diffuse large b cell lymphoma (lbcl) of any stage, including subtypes mediastinal large b cell, centroblastic, immunoblastic, t cell rich b cell and anaplastic b cell lymphoma, who will receive standard r/chop as first line chemotherapy will be included. * patients must be age 18 or older. * no selection will be made on the basis of gender, race or ethnicity. exclusion criteria: * patients will be excluded if the diagnosis of diffuse large b cell lymphoma cannot be confirmed. * patients receiving treatment other than r/chop or r/chop followed by radiotherapy or who have previously been treated for dlbcl will be excluded. - patients with hiv infection will also be excluded. no selection will be made based on other medical problems or laboratory values, except as they affect the patient's eligibility to receive standard r/chop chemotherapy as determined by the treating physician. * patients who have magnetic metal implants or fragments in their body that are incompatible with mri will be excluded.

Keywords: dmri diffusion mri diffuse large b-cell lymphoma dlbcl
study to evaluate efficacy and safety of pulmicort respules in japanese adult asthmatic patients

Conditions: Asthma

Summary: the primary objective of the study is to show similarity of efficacy on pulmicort respules 1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of pulmicort turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in japanese adult asthmatic patients with age of 16 years or older.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures. * a minimum of 6 months documented history of asthma according to the jgl 2006 definition * asthma patients under prescribed treatment with ics at least 3 months before visit 2. exclusion criteria: * current or previous tobacco smokers with a history of \>= 10 pack-years * use of β-blockers including eye drops * clinically significant respiratory infection affecting the asthma, as judged by the investigator(s) within 4 weeks prior to visit 2 * intake of oral, rectal or parenteral gcs within 4 weeks prior to visit 2

Keywords: asthma pulmicort respules
seasonal affective depression (sad) study

Conditions: Depressive Disorder

Summary: a placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of seasonal affective disorder

a 7-month multicenter, parallel, double-blind, placebo-controlled comparison of 150-300mg/day of extended-release bupropion hydrochloride and placebo for the prevention of seasonal depressive episodes in subjects with a history of seasonal affective disorder followed by an 8-week observational follow-up phase

Eligibility criteria:
inclusion criteria: * history of major depressive disorder (mdd) with a seasonal pattern. exclusion criteria: * current or past history of seizure disorder or brain injury. * history or current diagnosis of anorexia nervosa or bulimia. * recurrent summer depression more frequently than winter depression. * primary diagnosis of panic disorder, obsessive compulsive disorder (ocd), post-traumatic stress disorder(ptsd), acute distress disorder, bipolar ii disorder or other psychotic disorders. * initiated psychotherapy within the last 3 months.

Keywords: winter depression, winter blues, depression, seasonal depression, seasonal affective disorder
prevalence of gastroesophageal reflux disease (gerd) in patients with upper gastrointestinal tract symptoms in egypt

Conditions: Patients With Upper Gastro-intestinal Symptoms

Summary: the purpose of this study is to calculate the prevalence of gastroesophageal reflux disease (gerd) by mean of gerd-q questionnaire in patients with upper gastrointestinal tract symptoms in egypt.

prevalence of gastroesophageal reflux disease (gerd) in patients with upper gastrointestinal tract symptoms in egypt

Eligibility criteria:
inclusion criteria: * 18 years and above * attending the medical office and reporting symptoms suggestive of upper gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain, bloating, belching and nausea/vomiting. exclusion criteria: * participating on a clinical trial during the last 3 months. * patients not able to read and/or understand the gerd-q questionnaire. * patients already included in the study in other participating site. * patients taking ppis or h2blockers in the l

Keywords: upper gastro-intestinal symptoms, gerd
anti-h. pylori effect of deep see water

Conditions: Helicobacter Pylori Infection

Summary: deep sea water (dsw) is characterized by high purity, low temperature, high nutrients and minerals and is obtained from the water flows 200 meters under the surface of the sea. the inhibition of h. pylori growth by dsw has been demonstrated in vitro study. however, up to now, there is few randomized control study to evaluate the anti-bacterial effects of ingesting dsw in patients with h. pylori infection. the aims of this study are: 1. to evaluate the anti-bacterial effects of ingesting dsw in patients with h. pylori infection; 2. to evaluate the patient adherence and adverse effects of ingesting dsw.

patients having h. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars will be recruited. before treatment, h. pylori infection status will be examined by endoscopy with biopsy or 13c-urea breath test (13c-ubt). all patients will receive 13c-ubt before treatment, at the end of 2 week's treatment and 4 weeks after termination of treatment. a computed generated random numbers sequence will be blocked (2:1; block sizes of six) into two groups, say a and b. group a - ingesting dsw 200 cc four times a day (one hour before meal and bed time); group b - ingesting non-dsw drinking water 200 cc four times a day (one hour before meal and bed time). to keep the study in double-blind model, the picture of package for dsw and non-dsw drinking water will be the same. prokinetics (metoclopramide 5 mg/tab 1 tid) and antacid (strocain tablet (oxethazaine 5 mg and polymigel 244 mg/tab) 1 tid) will be permitted for relieving the dyspeptic symptoms. all patients will be asked to complete a questionnaire and to record symptoms and water/drug consumption daily during the treatment period. post-treatment, the patients will be seen at the outpatients clinic to investigate patient adherence and adverse of treatment.

Eligibility criteria:
inclusion criteria: * patients having h. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars who are aged greater than 20 years and are willing to received anti-h. pylori treatment. exclusion criteria: * pregnant or nursing woman * serious concomitant illness and malignant tumor of any kind * serious bleeding from gastrointestinal tract * previous gastric surgery * receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.

Keywords: helicobacter pylori deep see water
the prospective study of standard treatment of graves disease iodine 131 and prevention of adverse reactions

Conditions: Hypothyroidism; Exophthalmos

Summary: iodine 131 (131i） treatment on graves disease and graves ophthalmopathy relationship has always been the focus of debate. majority view is that the current treatment does not increase 131i graves ophthalmopathy, therefore,graves disease associated with exophthalmos is not a contraindication of 131i treatment. while treatment with corticosteroids, a timely corrective measures to be effective in preventing graves ophthalmopathy adverse effects. but the merger with severe proptosis in patients with graves , especially infiltrative exophthalmos , the application of 131i treatment will induce or aggravate not yet reached consensus, so, the 131i treatment is still very careful , mainly due to plaque prospective study and visual assessment is not lack of uniform standards, and a variety of factors (including smoking, work status, and 131i treatment of thyroid doses, etc.) may also interfere or influence the ultimate effect of 131i on the graves ophthalmopathy. in the view of this situation graves disease patients with graves ophthalmopathy could be 131i treatment or not, how to dose adjustments, and the use of which required treatment with systemic issues such as research, explore treatment exophthalmos reduction and mitigation of increased proptosis reasonable treatment of symptoms. to further promote the standardization of 131i treatment of graves disease on basis.

no more description

Eligibility criteria:
inclusion criteria: * a typical clinical symptoms of graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (ft3, ft4, rtsh) and thyroid autoantibodies and imaging examinations to confirmed. exclusion criteria: * 131i treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy
early identification of clinical deterioration using a wearable monitoring device

Conditions: Clinical Deterioration; Hemodynamic Instability

Summary: this study aims to provide myriad of physiological parameters in patients admitted in an internal medicine department, and which are defined as being in an increased risk of clinical deterioration within the first 72-hours after admission. the investigators will also conduct a retrospective comparison between physiological changes in patients who did deteriorate to those who did not. this will form the basis for the development of an algorithm for early prediction and warning of physiological and clinical deterioration during the first 72-hours of admission.


Eligibility criteria:
inclusion criteria: * males and females 18 years old and above admitted to the internal medicine department * on admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high * the patient is assigned to a "monitoring bed" within the department * the patient has signed an informed consent form exclusion criteria: * lack of informed consent * it is known in advance that the patient cannot take part in the study for a 72-hours period (e.g. a patient that will be taken to surgery within the next 24 hours) * technical inability to attach the biobeat patch (bb-613pw) to the patients chest

Keywords: vital signs clinical deterioration early prediction non-invasive monitoring
intraoperative assessment of of burst wave lithotripsy (bwl)

Conditions: Renal Calculi; Ureteral Calculi

Summary: burst wave lithotripsy (bwl) is a novel method of urinary stone fragmentation that uses multi-cycle bursts of low amplitude ultrasound to induce stone fracture. this is in contrast to traditional extracorporeal shock wave lithotripsy (swl), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. this is a single-arm feasibility study to test the ability of bwl to comminute (fragment) stones in humans.

this is a two-center, single-arm, feasibility study. the two centers are located within the us and include: university of washington (uw) school of medicine and indiana university (iu) health urology clinic. the investigative study will be performed in the operating room prior to a standard-of-care (soc) ureteroscopic (urs) laser lithotripsy procedure. the subject will already be under anesthesia. stones will be limited to ≤ 12 mm. the study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 20 subjects). all subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. the output parameters are nominally defined as: * 350 kil0hertz (khz) acoustic frequency * 7 megapascals (mpa) peak negative pressure * 20 cycle pulse duration * 17 hz pulse repetition frequency a maximum of 3 stones can be treated per subject. safety will be monitored by visual observation of the tissue with an ureteroscopic camera, the self-reported occurrences of adverse events, and occurrences of unplanned emergency department or clinic visits. fragmentation will be measured by visual observation with an ureteroscopic camera and direct measure of stones removed by basket after the procedure.

Eligibility criteria:
inclusion criteria: * individuals presenting with at least one kidney stone apparent on ct * individuals scheduled for clinical stone removal via ureteroscopy (urs) exclusion criteria: * individuals under 18 years of age * individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.) * individuals with uncorrected bleeding disorders or coagulopathies * individuals taking a clinically significant anticoagulant dose at the time of the procedure * individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm * individuals with a solitary kidney * individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the bwl procedure
the efficacy and neurobehavioural mechanism of n-acetyl cysteine (nac) for alcohol dependence

Conditions: Alcohol Dependence

Summary: the study will explore the efficacy and tolerability of a regimen of nac (2400 mg) versus placebo for the treatment of alcohol dependence.

study 1: relapse prevention: this is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive oral nac (2400 mg: 2x 600mg tablets twice per day) or matching placebo. trial participants will receive either oral nac ( dose stated above) or matching placebo for up to 4 weeks. study 2: withdrawal: trial participants will receive oral nac (dose stated above) or matching placebo within the first 24 hours of their admission for up to 3 days. study 3: participants from the relapse prevention substudy will also receive 30-minute non-invasive brain imaging session prior to and after completing the treatment regime in study 1. both males and females will be recruited for the study.

Eligibility criteria:
inclusion criteria: * male and female patients between the ages of 18 and 65 meeting dsm-iv criteria for current alcohol use disorder (this is an exclusion for the healthy control sample) * able to understand and sign written informed consent * must have a stable residence and be able to identify an individual who could locate subject if needed * admitted for medical detoxification from alcohol (withdrawal study only) * blood alcohol concentration of 0.00 (if completing brain imaging session) * express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only) exclusion criteria: * clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern. * pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control * women who are breastfeeding * dependence on any substance other than nicotine * court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only) * treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only) * dependence on any substance other than nicotine the following exclusion criteria are only applicable to participants undergoing the brain imaging session: * extreme obesity * pregnant or have any reason to believe they are pregnant; * previous brain surgery; * ever employed as a machinist, a welder or a metal worker; * epilepsy * metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.
austrian left atrial appendage closure registry

Conditions: Atrial Fibrillation; Left Atrial Appendage Closure

Summary: left atrial appendage (laa) occlusion (laac) has been introduced to treat patients with indication of oral anticoagulation (oac) for atrial fibrillation (af) with contraindication to oac. this registry aims to document all laac procedures in austria.


Eligibility criteria:
inclusion criteria: * patients who received laac in austria exclusion criteria: * absence of informed consent